Letter from the Director - 2020 Q2

We are approaching the 6-month mark for the consolidation of all the legacy IRBs into the new NIH Intramural IRB (NIH IRB).  I know that this has not been the easiest transition for the NIH community, and I thank you for your support and patience as we continue to build our new organization.  Our goal is to serve the intramural research community by providing optimal protections for our research subjects and facilitating the ethical conduct of the life-saving research conducted here at NIH.

Despite the challenges of an entirely remote workforce, the IRB continues to improve its metrics.  The IRB is receiving approximately 400 forms submitted each month.  The mean time to approval in May for new studies, amendments and continuing reviews reviewed by the full board were 40, 46 and 28 days respectively.  For forms approved by the expedited path, initial reviews were approved in 13 days, amendments in 14 days and continuing reviews in 11 days.  We continue to examine our processes to identify areas for increased efficiencies.

We have prioritized all COVID research, and the mean approval times for COVID related research were 4.5 days for initial reviews, 5.7 days for amendments, 2 days for NHSR determinations and 5.5 days for institutional approvals for multi-site research in which we are relying on an external IRB.  These truly amazing stats reflect the incredible hard work and dedication of the entire OHSRP staff that have dropped everything and worked many long hours to move these studies from submission to approval.  I can’t thank them enough for their dedication.

We have begun exploring the feasibility of replacing iRIS with a new electronic IRB system.  A steering committee made up of representatives from the ICs, the Assembly of Scientists and OHSRP have met once to discuss the process for evaluating the current landscape of systems.  While we cannot have a committee that has representation from every IC, rest assured that we will be soliciting direct input from the entire research community throughout the entire process.  Our goal is to find a system that serves our entire research community well, is forward looking and can grow as clinical research grows at the NIH.  I expect that this will be a long process, and in the meantime, we will continue to optimize iRIS.

As I said when I first arrived here, we can only succeed as a human research protection program (HRPP) if we work collaboratively with our investigator community.  I am grateful that the investigator community has been so willing to work with us and help us understand how best to serve their needs and those of our research participants.  The NIH can be a challenging place from an organizational standpoint.  I was asked recently, what do I know now that I wish I knew earlier.  My response was that when I arrived here, I thought the NIH was like a University with 27 different departments.  I now know it is more like 27 different Universities.